FDA delay

PTC’s drug plans hit by FDA data request

PTC faces FDA hurdles for two drug candidates, delays filing

Anika Sharma

PTC Therapeutics finds itself in a regulatory whirlwind, as the latest third-quarter results reveal hurdles and setbacks impacting the biotech’s ...

Iovance Biotherapeutics, FDA, FDA delay, cell therapy, tumor-infiltrating lymphocyte, Prescription Drug User Fee Act Date, PDUFA, melanoma

Iovance’s cell therapy for skin cancer faces three-year delay due to FDA issues

Anika Sharma

The FDA has introduced a new twist in the ongoing Iovance Biotherapeutics saga, causing further delays in the approval process ...